UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019982 |
|---|---|
| Receipt number | R000023072 |
| Scientific Title | The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery: a double-masked, placebo-controlled, randomized clinical trial |
| Date of disclosure of the study information | 2015/11/29 |
| Last modified on | 2017/11/25 14:19:39 |
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Basic information
Public title
The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery: a double-masked, placebo-controlled, randomized clinical trial
Acronym
The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery
Scientific Title
The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery: a double-masked, placebo-controlled, randomized clinical trial
Scientific Title:Acronym
The postoperative analgesic effect of single-shot retrolaminar block for breast cancer surgery
Region
| Japan |
Condition
Condition
Breast cancer surgery
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The postoperative analgesic effect of retrolaminar block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of patients who need analgesics within 12 hours after surgery
Key secondary outcomes
1. The number of patients who need antiemetics within 12 hours after surgery
2. Numerical pain rating scores within 3 hours after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Single-shot retrolaminar block with total 30mL of 0.5% ropivacaine
Interventions/Control_2
Single-shot retrolaminar block with total 30mL of normal saline
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. ASA physical status 1 - 2
2. Under general anesthesia
3. Breast cancer surgery with axillary lymph node dissection
Key exclusion criteria
1. Estimated glomerular filtration rate < 60 mL / min / 1.73 * square meter
2. NYHA classification > II
3. Hugh-Jones classification > II
3. Active phase peptic ulcer
4. BMI < 15 or BMI >= 35
5. Skin lesion at a block site
6. Allergies to local anesthetics, pentazocine or NSAIDs
7. Past history of severe postoperative nausea and vomiting
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mamoru Murakami |
Organization
Tohoku Kosai Hospital
Division name
Department of anesthesiology
Zip code
Address
2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL
+08-22-227-2211
masuiker@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Murakami |
Organization
Tohoku Kosai Hospital
Division name
Department of anesthesiology
Zip code
Address
2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL
+08-22-227-2211
Homepage URL
masuiker@gmail.com
Sponsor or person
Institute
Tohoku Kosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku Kosai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Tohoku Kosai Hospital (Miyagi)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 17 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 29 | Day |
Last modified on
| 2017 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023072
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
